Event:
On March 17, 2022, the Geneva medicines patent pool (MPP) announced that it had signed agreements with 35 pharmaceutical companies to allow them to produce nimatrilvir API or preparation, one of the components of Pfizer covid-19 oral drug paxlovid. Including 5 Chinese enterprises, namely Shanghai desaino, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) , Apeloa Pharmaceutical Co.Ltd(000739) , Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) . Kyushu pharmaceutical only produces APIs, Apeloa Pharmaceutical Co.Ltd(000739) , Shanghai Desano, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) and Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) can produce APIs and preparations at the same time.
Comments:
This authorization will further expand the market space of Pfizer covid-19 oral drug paxlovid. ① According to the terms of the agreement of this authorization, 35 qualified generic drug companies licensed worldwide will be able to provide Pfizer covid-19 oral drug paxlovid combination therapy to 95 countries / regions, covering about 53% of the world's population, including all low-income and middle and low-income countries in sub Saharan Africa and some middle and high-income countries, as well as countries that have changed from low-income to middle and high-income in the past five years. Previously, paxlovid has obtained approval / emergency use authorization in the UK, Canada, the United States and Japan. In February 2022, paxlovid was conditionally approved for import registration in China and included in the ninth edition of covid-19 diagnosis and treatment guide. According to Pfizer's 2021 annual report data, paxlovid production is expected to reach 30 million courses in the first half of 2022, 90 million courses in the second half of 2022 and 120 million courses in the whole year (excluding the Chinese market). With the global sales of paxlovid MPP agreement, its market space is further expanded. This authorization will enable paxlovid industrial chain to expand. Paxlovid is a compound preparation composed of 3CL protease inhibitor nirmatrelvir (pf-07321332) and ritonavir. According to the description of science, nirmatrelvir consists of three fragments, in which SM1 and SM2 synthesize fragment 1 and fragment 2. Fragment 1 is synthesized by multi-step reaction of SM1, which is also called cyclic glutamine analogue. The synthesis of SM1 has technical barriers such as ultra-low temperature of - 120 ℃ and qualification of cyanide raw material reaction. SM2 is also called compound 77-1. SM2 needs to be obtained from the reaction of carbonic anhydride, which is derived from the reaction of carbonic acid. The acquisition of carbonic acid mainly consists of three processes: ethyl inulin route, Kungfu acid route and isopentenol route. There are steps for the synthesis of carbonic anhydride to SM2, which requires enzymatic method, and it is difficult to control the synthesis process of some steps. To sum up, the technical barrier of paxlovid synthesis route is high. This authorization will make paxlovid upstream industrial chain large-scale, and the authorized preparation and API companies in China will benefit greatly. In addition, China's Asymchem Laboratories (Tianjin) Co.Ltd(002821) , Porton Pharma Solutions Ltd(300363) and other cdmo companies have announced that they have obtained covid-19 small molecule large orders, Asymchem Laboratories (Tianjin) Co.Ltd(002821) announced orders of US $481 million and RMB 2.720 billion on November 17, 2021 and November 29, 2021 respectively, Porton Pharma Solutions Ltd(300363) announced orders of US $217 million and RMB 681 million on November 30, 2021 and February 11, 2022 respectively, and the order supply time is up to 2022. With the large volume of paxlovid, China's authorized preparation and API companies and some cdmo enterprises are expected to usher in performance increment.
Investment suggestion: covid-19 oral medicine is an important part of covid-19 treatment industry chain. This authorization will further expand the market space of Pfizer covid-19 oral medicine paxlovid and its market prospect is broad. It is suggested to pay attention to the authorized enterprises Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) ( Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) ), Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) ( Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) ), Kyushu Pharmaceutical ( Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) ) and Apeloa Pharmaceutical Co.Ltd(000739) ( Apeloa Pharmaceutical Co.Ltd(000739) ); Cdmo enterprises deeply involved in the global covid-19 small molecule supply chain Wuxi Apptec Co.Ltd(603259) ( Wuxi Apptec Co.Ltd(603259) ), Asymchem Laboratories (Tianjin) Co.Ltd(002821) ( Asymchem Laboratories (Tianjin) Co.Ltd(002821) ), Porton Pharma Solutions Ltd(300363) ( Porton Pharma Solutions Ltd(300363) ), etc.
Risk warning: the risk of drug sales falling short of expectations; The risk of intensified market competition; Production safety accidents and drug quality risks, etc.
